Composition and method for moisturizing nasal tissue

ABSTRACT

An improved composition and method for moisturizing a nasal membrane are disclosed. The composition includes a viscous carrier and one or more moisturizing agents disposed with the carrier. The composition is applied to a portion of a nasal membrane using a spray, a swab applicator, or a similar application device.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. Pending patentapplication Ser. No. 09/388,816, entitled “METHOD AND COMPOSITION FORDELIVERING ZINC TO THE NASAL MEMBRANE” and filed on Sep. 1, 1999, whichis a continuation-in-part of U.S. patent application Ser. No.09/145,042, entitled “METHOD AND COMPOSITION FOR DELIVERING ZINC TO THENASAL MEMBRANE” and filed on Sep. 1, 1998; and is a continuation-in-partof U.S. Pending patent application Ser. No. 09/956,744, entitled “METHODAND COMPOSITION FOR DELIVERING ZINC TO THE NASAL MEMBRANE” and filed onSep. 12, 2001; which is a continuation of U.S. patent application Ser.No. 09/145,042, entitled “METHOD AND COMPOSITION FOR DELIVERING ZINC TOTHE NASAL MEMBRANE” and filed on Sep. 1, 1998.

TECHNICAL FIELD

[0002] The present invention generally relates to a method andcomposition for moisturizing nasal tissue.

BACKGROUND INFORMATION

[0003] Compounds suitable for moisturizing a nasal cavity or a portionof a nasal cavity are desirable for several reasons. For example,application of a moisturizer to the nasal cavity may facilitate and/orpromote healthy function of the cavity, which in turn may reduce theduration of symptoms associated with, for example, a common cold or theflu, and which may reduce the likelihood of an infection in the nasalregion.

[0004] In general, the nasal cavity performs several functions. Thelower portion of the cavity includes the nasal epithelium, which is anessential part of the respiratory tract. The nasal epithelium is veryvascular, which allows the epithelium to warm inspired air. Theepithelium is also relatively moist, which allows it to moisten andcleanse inspired air. The cavity also includes a mucous membrane whichlines the nasal cavity and traps fine particles such as dust, pollen andsmoke.

[0005] Nasal epithelial cells play an important role in warding of bothbacteria and viruses. The cells act as a chemical, mechanical andmicrobiological barrier to infection. Typically, small glands within thenose secrete mucus, onto the nasal epithelial cells to moisten a portionof the nasal membrane. The cilia, hair like structures implanted in theepithelium and the immune system's first line of defense, are the cellsresponsible for trapping dust and bacteria. When the nasal membranebecomes dry, the cilia's movement slows and bacteria are better able toenter the respiratory system. To effectively function, the epithelialcells must generally be healthy and moist.

[0006] Substances within air often act to irritate and dry out the nasalcavity. Sinusitis and allergens are two common conditions that affectthe proper functioning of the nasal membrane. Sinusitis is an infectionof any of the four groups of sinuses that prevents the proper drainageof mucous in the sinus passages. Sinusitis may stem from a cold or flu,allergies, pollution, injuries or various other conditions, which oftenresult in a dry nasal passage.

[0007] Inhaled allergens, including dust, pollen, molds, animal dander,and grass may react with the mucous membrane. This reaction may resultin a drying or irritation of the nasal cavity. These factors along withdry climates, changing seasons, and pollution can all lead to nasalcavity dryness which may cause cracking and bleeding of the nose as wellas various other acute or chronic conditions. Accordingly, methods andcompositions for moisturizing a nasal membrane are desired.

[0008] Presently, common treatment for nasal membrane dryness is eitheruse of low-viscosity composition nasal sprays or use of a humidifier.Low-viscosity, over the counter nasal sprays generally remain in thenasal cavity only for a short period of time and therefore may berelatively ineffective at treating dry nasal cavities. A humidifiergenerally requires that the subject utilizing the humidifier remainproximate to the humidified air for a period of time and such use maytherefore be problematic or undesirable in some instances. Accordingly,improved compositions, systems and methods for moisturizing the nasalmembrane are desired.

SUMMARY OF THE INVENTION

[0009] The present invention provides improved methods and compositionsfor moisturizing the nasal membrane.

[0010] While the way in which the present invention addresses thedisadvantages of the prior art will be discussed in greater detailbelow, in general, the present invention provides an effective nasalmoisturizer that does not irritate nasal epithelium.

[0011] In accordance with one exemplary embodiment of the presentinvention, the nasal moisturizer is a composition that includes anactive moisturizing ingredient within a viscous gel. The gel has aviscosity in the range of 2,500 to 40,000 centipoise, preferably in therange of 5,000 to 20,000 centipoise. The active ingredient may includeany number of materials appropriate for moisturizing nasal tissue. Inaccordance with one aspect of this embodiment of the invention, thenasal moisturizer is configured to facilitate maintaining thecomposition within the nasal membrane for a period of time long enoughto effectively moisturize the nasal membrane.

[0012] In accordance with another embodiment of the invention, a nasalmoisturizer includes a gel and an encapsulated moisturizing agent. Inaccordance with one aspect of this embodiment, the gel includes purifiedwater and glycerin. In accordance with another aspect of this embodimentof the invention, the moisturizing agent includes aloe barbadensis gel.In accordance with a further aspect of this embodiment, the compositionincludes a thickener.

[0013] In accordance with another embodiment of the invention, thecomposition includes a nasal moisturizing agent encapsulated withinlipid or liposomal vesicles. In accordance with various aspects of thisembodiment, lipid or liposomal vesicles are formed of unilamellarvesicles or multilamellar vesicles.

[0014] In accordance with another embodiment of the invention, a methodof treating a dry nasal membrane includes applying a nasal moisturizingcomposition to the nasal cavity using a nasal spray, aerosol or swabapplicator.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0015] The present invention provides an improved composition forrelieving symptoms of a dry nasal membrane and a method of using thesame. The invention is conveniently described herein in terms of a highviscosity nasal moisturizing compound that can be easily applied throughuse of a nasal or aerosol spray, swab applicator or the like. It shouldbe appreciated that the functional composition may be realized by anynumber of combinations of the ingredients listed below. For example, thecomposition may vary in its viscosity level, which will allow thecomposition to be suitably configured for various intended applications.

[0016] The nasal moisturizing composition of the present inventiongenerally includes a carrier and one or more active ingredientsdispersed within the carrier. In accordance with various embodiments ofthe invention, the composition includes about 80-99.999 weight percentand preferable about 90-99.999 weight percent of a carrier. The carrierincludes ingredients that are compatible with the nasal membrane andwhich form a composition having a viscosity high enough to maintain thecomposition in contact with the nasal membrane for an extended period oftime. An exemplary carrier composition includes purified water, glycerinand a suitable thickening agent, and has a viscosity of about2,500-40,000 centipoise and preferably about 5,000-20,000 centipoise, asmeasured using the Brookfield Syncho-Lectric Viscometer for themeasurement of the apparent viscosity of newtonian and non-newtonianmaterials at low shear rates at given rotational speeds. The highviscosity carrier allows the composition to maintain contact with thenasal cavity without being drawn out by gravity or other forces which inturn allows active ingredient(s) within the carrier to remain proximateto or in contact with the nasal membrane.

[0017] In accordance with one exemplary embodiment of the invention thecomposition includes about 95-97 weight percent purified water and about0.75-1.25 weight percent glycerin which are mixed together to form acomposition as discussed in more detail below, the composition may alsoinclude a thickener to further increase the viscosity of thecomposition.

[0018] The active ingredients in the compositions of the presentinvention may be selected to perform a desired function. In accordancewith various embodiments of the invention, the active ingredientsinclude agents that act to moisturize the nasal tissue withoutirritating the nasal cavity. The active ingredients may include, but arenot limited to, moisturizing agents such as, glycerin, aloe barbadensisgel, tocopherol and the like. In accordance with one exemplaryembodiment of the invention the composition includes about 0.001-2.0weight percent active ingredient, and preferably about 0.002 to 1.25weight percent.

[0019] The composition may also include various optional ingredientssuch as additional thickeners, buffers, antibacterial agents and/oranti-microbial agents and/or preservatives to preserve and/or stabilizethe formulations for manufacturing and storage. A buffer is used tomaintain physiological pH. The composition may include any buffer thatis capable of maintaining the desired pH. Exemplary buffers include, butare not limited to, sodium phosphate (monohydrate)/disodium phosphate(heptahydrate), sodium bicarbonate, and monobasic potassiumphosphate/sodium hydroxide. A preservative maintains the sterility ofthe nasal moisturizer and may be used to extend the shelf life of thecomposition. Exemplary preservatives include, but are not limited tobenzalkonium chloride, phenycarbinol and thimerosal. An antibacterialagent maintains the sterility of the composition and may also inhibitbacteria reproduction inside the nasal cavity. Exemplary antibacterialagents include, but are not limited to, hydrolyzed algin and chlorellavulgaris extract. An anti-microbial agent maintains the sterility of thecomposition, stabilizes the composition and may also kill pathogensinside the nasal cavity. Exemplary anti-microbial agents include, butare not limited to, chlorobutanol, sulfur dioxide, tetracycline, sorbicacid, ethanol, chlorohexidine, terconazole, nystatin, clotrimazole, andbutoconazole.

[0020] The nasal moisturizing composition may also include any one ormore of additional pharmaceutical and/or cosmetic agents. These agentsmay facilitate the preservation of the composition. Exemplarypharmaceutical or cosmetic agents include, for example, benzyl alcohol,disodium EDTA, hydroxylated lecithin, alkoylated diester, polysorbate80, polysorbate 65, and procaine hydrochloride.

[0021] One or more of the active ingredients may be encapsulated withinlipid or liposomal vesicles to facilitate time-release dispersement ofthe active ingredients. This encapsulated composition allows for theactive ingredient to be incorporated into the nasal tissue at a higherconcentration than the active ingredient's water or lipid solubility,thereby allowing for increased absorption of the active ingredient intothe nasal membrane.

[0022] As noted above, in accordance with various aspects of theinvention, the nasal moisturizing composition includes a moisturizingagent. The moisturizing agent may be either a water soluble or lipidsoluble composition that effectively moisturizes epithelial tissue. Themoisturizing ingredient may also include a humectant. A humectant is asubstance that promotes the retention and absorption of moisture fromthe air. Exemplary humectants include, but are not limited to glycerin,polyethylene glycol, polypropylene glycol, urea, sodium pyroglutamate,amino acids and the like. In accordance with one embodiment of theinvention the humectant is glycerin.

[0023] In accordance with an alternative embodiment of the invention,the nasal moisturizing composition includes purified water, one or morethickeners and a moisturizing agent. The purified water is the solventfor the composition and acts to maintain the composition's properviscosity level. The thickeners operates to increase the viscosity levelof the composition to a level high enough to maintain the composition incontact with the nasal membrane for a period of time long enough tomoisturize the nasal tissue. The thickener may include, but is notlimited to glycerin and hydroxyethylcelluose.

[0024] In further accordance with this embodiment, the compositionincludes one or more active ingredients dispersed within the carrier. Inaccordance with various aspects of this embodiment, the activeingredients act to moisturize the nasal tissue without irritating thenasal cavity. The active moisturizing ingredients may include, but arenot limited to moisturizing agents such as, glycerin, aloe barbadensisgel, tocopherol and the like.

[0025] In accordance with another aspect of this exemplary embodiment ofthe invention, the moisturizing composition includes one or more timerelease active ingredients dispersed throughout the composition. Inaccordance with one aspect of the invention, the time release ingredientis encapsulated within lipid or liposomal vesicles. The lipid orliposomal vesicles are formed, for example, of unilamellar vesicles ormultilamellar vesicles as described in U.S. Pat. No. 6,048,545. Inaccordance with another aspect of this embodiment, the moisturizingagents may include moisturizing agents such as, glycerin, aloebarbadensis gel, tocopherol and the like.

[0026] Each of the embodiments and each of the compositions are suitablefor application to the nasal membrane using a swab applicator, a sprayapplicator or other device. The swab applicator is a device that fullyencapsulates both the composition and the applicator. Each swabapplicator device includes a desired amount of the composition, forexample, approximately one ounce of composition and a sterile cottonswab applicator encased and sealed in a plastic tube. In this case eachdevice has approximately enough composition for one application.

[0027] The example provided below illustrates an exemplary nasalmoisturizing compound of the present invention. The example is providedfor illustration purposes only. This invention is not limited to thespecific example provided herein. Weight Percent Components RangeExemplary Value Purified Water    95-100.00 95.522% Sodium Phosphate1.500-3.000 1.5% Hydroxyethylcellulose 1.000-1.500 1.0% DisodiumPhosphate 1.000-1.500 1.0% Glycerin 0.750-1.250 0.75% Alkoylated Diester0.001-0.500 0.001% Aloe Barbadensis Gel 0.001-0.250 0.001% HydrolyzedAlgin 0.001-0.060 0.001% Chlorella Vulgaris Extract 0.001-0.060 0.001%Sea Water 0.001-1.000 0.001% Benzalkonium Chloride 0.010-0.100 0.01%Benzyl Alcohol 0.200-0.500 0.20% Disodium EDTA 0.010-0.100 0.01%Hydroxylated Lecithin 0.001-1.000 0.001% Tocopherol 0.001-0.100 0.001%Polysorbate 80 0.001-0.100 0.001%

[0028] The solution is prepared by admixing the various componentstogether.

[0029] The present invention has been described above with reference toexemplary embodiments. Those skilled in the art having read thisdisclosure will recognize that changes and modifications may be made tothe embodiments without departing from the scope of the invention. Forinstance, the present invention has been described in connection withparticular active moisturizing agents; however, various other activeingredients may suitably be used with the moisturizing compounds of thepresent invention. These and other changes or modifications are intendedto be included within the scope of the present invention, as expressedin the following claims.

We claim:
 1. A composition for moisturizing a nasal membrane comprising;a gel having a viscosity greater than about 2,500 centipoise, whereinsaid composition is configured to moisturize a nasal membrane.
 2. Thecomposition of claim 1, wherein said composition comprises purifiedwater and glycerin.
 3. The composition of claim 2, wherein saidcomposition comprises about 80 to 99.999 weight percent purified water,and about 0.5 to about 1.5 weight percent glycerin.
 4. The compositionof claim 1, wherein said composition further comprises a moisturizingagent selected from the group consisting of glycerin, aloe barbadensisgel, and tocopherol.
 5. The composition of claim 1 further comprising athickener.
 6. The composition of claim 1 further comprising a materialselected from the group consisting of an antibacterial agent andanti-microbial agent.
 7. The composition of claim 6, wherein saidantibacterial agent comprises a material selected from the groupconsisting of chlorella vulgaris extract and hydrolyzed algin.
 8. Thecomposition of claim 1, further comprising a buffer.
 9. The compositionof claim 8, wherein said buffer comprises a material selected from thegroup consisting of sodium phosphate (monohydrate) and disodiumphosphate (heptahydrate).
 10. The composition of claim 1, furthercomprising a preservative.
 11. The composition of claim 1, furthercomprising a material selected from the group consisting of benzalkoniumchloride, disodium EDTA and benzyl alcohol.
 12. The composition of claim1, further comprising a material selected from the group consisting ofalkoylated diester, sea water, hydroxylated lecithin and polysorbate 80.13. The composition of claim 1, further comprising an encapsulate and anactive ingredient within said encapsulate.
 14. The composition of claim13, within said active ingredient comprises a moisturizing agent.
 15. Acomposition for moisturizing a nasal membrane comprising; purifiedwater; a hydrophilic thickener; and a moisturizing agent.
 16. Thecomposition of claim 15, wherein said composition comprises: about 80 to99.9999 weight percent purified water; about 0.5 to 2.0 weight percenthydrophilic thickener; and about 0.0001 to 2.25 weight percentmoisturizing agent.
 17. The composition of claim 16, wherein saidcomposition comprises: about 90 to 99.999 weight percent purified water;about 1.0 to 1.5 weight percent hydrophilic thickener; about 0.001 to1.0 weight percent moisturizing agent.
 18. The composition of claim 15,wherein said moisturizing agent comprises a humectant.
 19. Thecomposition of claim 15, wherein said hydrophilic thickener compriseshydroxyethylcellulose.
 20. The composition of claim 15, wherein saidmoisturizing agent comprises a material selected from the groupconsisting of glycerin, aloe barbadensis gel, and tocopherol.
 21. Thecomposition of claim 15, further comprising a material selected from thegroup of sodium phosphate (monohydrate), disodium phosphate(heptahydrate), hydrolyzed algin, chlorella vulgaris extract, alkoylateddiester, sea water, disodium EDTA, hydroxylated lecithin, polysorbate80, benzyl alcohol, and benzalkonium chloride.
 22. A system for sprayingthe composition onto a portion of a nasal cavity comprising thecomposition of claim
 15. 23. A composition for moisturizing a nasalmembrane comprising; a gel; a time-release moisturizing agent.
 24. Thecomposition of claim 23, wherein said time-release agent is encapsulatedin a liposomal agent.
 25. The composition of claim 23, wherein saidmoisturizing agent comprises a material selected from the groupconsisting of glycerin, aloe barbadensis gel, and tocopherol.
 26. Thecomposition of claim 23, further comprising a material selected from thegroup consisting of an antibacterial agent and an anti-microbial agent.27. The composition of claim 26, wherein said antibacterial agentcomprises a material selected from the group consisting of chlorellavulgaris extract and hydrolyzed algin.
 28. The composition of claim 23,wherein said composition comprises a material selected from the groupconsisting of sodium phosphate (monohydrate), disodium phosphate(heptahydrate), hydroxyethylcellulose, alkoylated diester, sea water,disodium EDTA, hydroxylated lecithin, polysorbate 80, benzyl alcohol,and benzalkonium chloride.
 29. A method of moisturizing a nasalmembrane, the method comprising the steps of: providing a compositionhaving a viscosity greater than about 2,500 centipoise; applying thecomposition to the nasal membrane in an amount effective to moisturizethe nasal membrane; and maintaining the composition in contact with thenasal membrane for a time period sufficient to moisturize the contactednasal membrane cells.
 30. The method of claim 29, wherein said applyingstep comprises applying the composition with a cotton swab.
 31. Themethod of claim 29, wherein said applying step comprises applying thecomposition with a nasal spray.